MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-LAP CHOLE PACK-LF

Model Number DYNJ21888S

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

White plunger is coming off the mounts when being used in a normal way- component 91881c.

Manufacturer Narrative

It was reported that white plunger is coming off the mounts when being used in a normal way component 91881c.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: DBD-LAP CHOLE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brandon kroeger ; three lakes drive; northfield, IL 60093 ; 8479492650
• MDR Report Key: 19015360
• MDR Text Key: 339127846
• Report Number: 1423395-2024-00256
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ21888S
• Device Lot Number: 23BMG819
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other